In the United States and across the world, a major complication associated with surgical procedures is the development of an incisional hernia. As high as 10% of open abdominal operations will be complicated by the development of incisional hernias. An incisional hernia occurs when a weakness in the muscle of the abdomen allows the tissues of the abdomen to protrude through the muscle. The hernia appears as a bulge under the skin, and can be painful or tender to the touch. In the case of an incisional hernia, the weakness in the muscle is caused by the incision made in a prior abdominal surgery. An incisional hernia may be small enough that only the peritoneum, of the lining of the abdominal cavity, pushes through. In severe cases, portions of organs may move through the muscle.
Repair rates of incisional hernias are even worse with some recurrence rates approaching 50%. Many biologic technologies are being developed to decrease the rate of hernia formation as well as to repair the hernias if they do occur.
Studies are currently being performed with indwelling catheter-based technologies allowing for drug delivery to the incisional site wherein the catheter provides saturation of the wound bed with various medicament-containing liquids. The distal end of the catheter is inserted in or around the wound site, secured to the patient with surgical sutures, surgical adhesive, bandages or the like, leaving an accessible proximal end portion of the catheter to allow for the infusion of therapeutic liquids through one or more proximal catheter ports.
Unfortunately, it commonly occurs that indwelling catheters lead to infections caused by cutaneous organisms mesh seeding along the catheter line into the incisional area at the site of implantation. Catheter infection, defined as the entrance of microorganisms at the site around or in the catheter, is a serious complication, particularly when a mesh is implanted for hernia repair. Microorganisms invariably gain access to the tract of the sheath and the catheter at the skin surface and grow inwards toward the surgical hernia area, contaminating the surgical site. The longer the duration of a transcutaneous catheter, the greater the risk of infection.
An infection arising from an indwelling transcutaneous catheter is an especially severe complication in surgical procedures involving hernia repair where a mesh is implanted to secure a hernial rupture. Invariably, the infection arising from the indwelling catheter will contaminate the entire area including the implanted mesh, giving rise to life threatening infections. Often, the entire infected mesh has to be removed as well as the infected tissue surrounding it.
Currently, there are no universal self-contained implantable hernia repair devices that allow for the testing and delivery of medicaments directly to the hernia repair site.
Accordingly, there is a need for a comprehensive hernia control, prevention, treatment and a system that avoids or, at least, decreases the chances of infection while strengthening the tissue surrounding hernias, or potential hernias. Such a system would provide general, as well as specific, remedies for the drawbacks of the conventional art.